Initiating Ketamine in Acutely Suicidal Patients in the Emergency Department

Summary

Current treatment for acutely suicidal patients are limited to hospitalization, psychotherapy, electro-convulsant therapy, or a combination of the aforementioned. However, this has added to the national boarding problem. Long term pharmacologic treatment for suicidal behaviors and mood stabilization has been studied in specific populations. In these populations, the decreases in suicidal ideation results from stabilization of the underlying psychiatric illness. Ketamine is most commonly used as an anesthetic with analgesic properties. It has been used off-label for pain management, procedural sedation, status epilepticus, and treatment resistant depression. It has been safely administered intravenously and well tolerated for chronic Post Traumatic Stress Disorder. It increases norepinephrine, dopamine, and serotonin through adrenergic neuron stimulation and prevention of catecholamine uptake. There is a strong corollary between stress and the development of depression and suicidal behaviors. It is proposed that the use of low dose intravenous ketamine may have benefit on the suicidal ideation of patients presenting to the Emergency Department.

Conditions

• Suicide
• Suicide Threat
• Depression Severe

Interventions

DRUG

Ketamine Hydrochloride

Experimental Procedure 1. Baseline evaluation of suicidal severity (BSSI) \& degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires. 2. The experimental and placebo arms will receive a single dose of IV ketamine, 0.5 mg/kg in 100 cc NS or 100 cc of NS infused over 40 minutes. 3. Post ketamine re-evaluation of outcome measures at four and twenty-four hours will determine clinical effectiveness of ketamine intervention 4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention. 5. Post ketamine re-evaluation of outcome measure at one-week post infusion will elucidate ketamine's durability of effect.

DRUG

Normal saline

Experimental Procedure 1. Baseline evaluation of suicidal severity (BSSI) \& degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires. 2. The placebo arms will receive a single dose of 100 cc of NS infused over 40 minutes. 3. Post Placebo infusion re-evaluation of outcome measures at four and twenty-four hours 4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention. 5. Post Normal Saline re-evaluation of outcome measure at one-week post infusion.

Sponsors & Collaborators

• Naval Medical Center Camp Lejeune

  lead FED

Principal Investigators

• Nathan H Butler, DO · Naval Medical Center Camp Lejeune

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-14

Primary Completion

2021-04-24

Completion

2022-02-16

FDA Drug

Yes

Countries

• United States

Study Locations